Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma (NCT00424515) | Clinical Trial Compass
CompletedPhase 2
Imatinib in Patients With Mucosal or Acral/Lentiginous Melanoma
United States24 participantsStarted 2006-07
Plain-language summary
The purpose of this study is to evaluate how effective imatinib (Gleevec) is in treating acral/lentiginous and mucosal melanoma which has spread to other parts of the body in patients who's disease carries a c-kit mutation. Imatinib is a protein-kinase inhibitor. It is believed that imatinib may be effective in blocking signals on certain cancer cells which allow the malignant cells to multiply and spread.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Melanomas that arise on chronically sun damaged skin and have pathologic evidence of solar elastosis
* History of primary mucosal or acral/lentiginous melanoma
* Histologically documented stage IV metastatic melanoma
* ECOG performance status 0,1, or 2
* Estimated life expectancy of 6 months or greater
* Age 18 years or older
* Creatinine \< 1.5 x ULN
* ANC \> 1500 ul
* Platelets \> 100,000 ul
* Total bilirubin, AST, and ALT \< 2 x ULN
* Amylase and lipase \< 1.5 x ULN
* C-kit mutation documented from either primary or metastatic tumor site
* \> 4 weeks from prior chemotherapy or investigational drug
* At least one measurable site of disease as defined by at least 1 cm in greatest dimension
Exclusion Criteria:
* Severe and/or uncontrolled medical disease
* Pregnant or nursing mothers
* Any other significant medical, surgical, or psychiatric condition that my interfere with compliance
* Patient is \< 5 years free of another primary malignancy except: basal cell skin cancer or a cervical carcinoma in situ
* Concurrent treatment with Warfarin
* Prior treatment with c-kit inhibitor
* Patient with Grade III/IV cardiac problems as defined by NYHA criteria
* No H2 blockers or proton pump inhibitors
* Known brain metastasis
* Known chronic liver disease
* Known diagnosis of HIV infection
* Previous radiotherapy to \> 25% of the bone marrow
* Major surgery within 2 weeks prior to study entry
* Patient has received any other investigational agent within 28 days…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best Overall Response
Timeframe: Disease was evaluated radiologically at baseline, after 6-weeks, and at 2-month intervals on treatment. Mean treatment duration was 4 months (range 1-11; amplified/mutated 3m/ 6m).